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A clinical trial to study the effects of adapalene, benzoyl peroxide, and benzoyl peroxide-clindamycin combination in patients having pimples.

A Randomized, open label, active controlled, parallel group trial to compare the safety and efficacy of adapalene, benzoyl peroxide, and benzoyl peroxide-clindamycin combination in patients with acne vulgaris.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003127
Enrollment
150
Registered
2012-11-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Mild to Moderate Acne vulgaris

Interventions

Intervention1: Adapalene: 0.1% thin film to be applied once daily at bed time for three months Control Intervention1: Benzoyl peroxide: 2.5% thin film to be applied once daily at bed time for three mo

Sponsors

Peoples college of medical sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy males, and non-pregnant females, aged 12-30 years with a clinical diagnosis of mild-moderate acne vulgaris. 2. Presence of Non-inflammatory lesions (comedones). 3. Presence of mild to moderate inflammatory lesions like papules and pustules (Grades 1 and 2).

Exclusion criteria

Exclusion criteria: 1. Acne patients with ages below 12years, or above 30 years. 2. Pregnant and nursing females. 3. Presence of severe inflammatory lesions of acne like nodulo-cystic lesions (Grades 3 and 4). 4. Presence of any other skin condition that would interfere with the diagnosis and assessment of acne vulgaris, (eg-on the face-rosaceae, dermatitis). 5. Excessive facial hair (eg-beard) that would interfere with diagnosis or assessment of acne vulgaris. 6. History of hypersensitivity or allergy to these drugs. 7. Use of any other drug for the treatment of acne vulgaris within 2 months. 8. Patients on hormonal treatment. 9. Patient on drugs causing acne as a side effect.

Design outcomes

Primary

MeasureTime frame
Acne severity index Total acne lesion countTimepoint: Acne severity index and Total acne lesion count will be assessed after 2 4 6 8 10 12 weeks.

Secondary

MeasureTime frame
Acne severity index Total acne lesion countTimepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Hanmant Amane

Peoples College of Medical Sciences and Research Centre

drhsamane25@gmail.com8717955345

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026